Manufacturing Biz #6 - Magazine - Page 40
additional clarity to support the predicted
growth of manufacturing activities in the
emerging in-orbit economy. In line with the
recommendations of the Space Regulatory
Review 2024 we are therefore developing new
guidance products and regulatory sandboxes
to support innovators and investors by
providing clarity and transparency on the
steps to licensing UK operated in-orbit
manufacturing platforms.
This will be in line with the UK’s nonprescriptive, outcome-focussed approach
where spaceflight licence applicants
demonstrate what steps they propose to
take to ensure that the risks associated
with their planned activities are as low as
reasonably practicable, including for the reentry and safe landing of platforms with the
manufactured products on board. To support
this activity, the Government is launching a
Re-entry Regulatory Sandbox. This sandbox
will aim to support re-entry activities, such
as IOM, and builds on the learnings from the
recent Rendezvous & Proximity regulatory
sandbox.
The CAA and government are also exploring
opportunities to streamline spaceflight
licensing processes, in particular to support
progression to larger-scale, higher cadence
operations.
The UK’s modern legislative frameworks for
human medicines and spaceflight activities
represent a unique opportunity to demonstrate
a clear end-to-end regulatory pathway for UK
in-space manufactured pharma products. To
promote investment into the UK and support
innovators seeking to seize this opportunity, the
UK Space Agency and MHRA are collaborating
to produce principles-based case studies
which illustrate the regulatory pathway to be
followed by space, biotech and pharmaceutical
companies.
Potential applicants for UK operated In-Orbit
Manufacturing platforms are encouraged to
engage with the CAA as early as possible to
discuss proposed missions by contacting the
CAA at commercialspaceflight@caa.co.uk.
Further information on the licensing process
can be found here - Space licensing in the UK.
“The UK’s modern
legislative frameworks
for human medicines
and spaceflight activities
represent a unique
opportunity to demonstrate
a clear end-to-end
regulatory pathway for
in-space manufactured
pharma products.”
Government initiatives
Alongside providing regulatory clarity
through the production of joint case studies
with the MHRA, the UK Space Agency is
leading a wide range of initiatives to drive
growth and development of the in-orbit
pharmaceuticals sector. This work contributes
directly to the ambitions of the Life Sciences
Sector Plan and the Modern Industrial
Strategy 2025 to support economic growth
and strengthen health outcomes for the
United Kingdom. These actions are intended
to provide coordinated support and clarity to
the supply chain on the adoption pathway. UK
Space Agency interventions include:
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M A N U FA C T U R I N G B I Z M A G A Z I N E A P R I L 2 0 2 6
Unlocking demand signals and
driving engagement and sector
understanding: Engaging with the NHS
and biopharma supply chain through
events and workshops, to build user
demand and explore the barriers faced
by different public and private sector
organisations along the adoption
pathway.
Undertaking a literature review of
experiments on the International
Space Station on pharmaceuticals
and biologics, to identify the UK’s
competitive advantage and capabilities
for future focused development.
Inaugural UK-Swiss Dialogue in June
2026, bringing experts and senior
decisionmakers from space and
pharma together for the first time,
to identify challenges and solutions to
advance microgravity for biopharma
R&D.
